Oncternal Therapeutics Updates Business and Announces Q2 2024 Financial Results

Oncternal Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of innovative oncology therapies, has provided a business update along with its financial results for the second quarter of 2024. The company is actively progressing with its ongoing clinical trials for ONCT-534 and ONCT-808, targeting advanced prostate cancer and aggressive B-cell lymphoma, respectively.

James Breitmeyer, M.D., Ph.D., President and CEO of Oncternal, shared positive updates on the ONCT-534 trial, highlighting that no dose-limiting toxicities or concerning side effects have been observed. This Phase 1/2 study involves patients with advanced prostate cancer who are resistant to currently approved androgen receptor pathway inhibitors. The sixth dosing cohort, administering 1200 mg of ONCT-534 orally once daily, has been completed with three patients enrolled and treated. Initial clinical and biomarker data from this study are anticipated in the third quarter of 2024.

Furthermore, the ONCT-808 trial, which focuses on patients with relapsed or refractory aggressive B-cell lymphoma, including those who have not responded to prior CD19 CAR T treatment, is actively enrolling participants. Oncternal has implemented protocol modifications to improve patient eligibility criteria, enhance early infection monitoring, and evaluate lower doses of ONCT-808. Clinical data updates from this study are expected in the fourth quarter of 2024.

Oncternal's recent financial results for the second quarter of 2024 include a grant revenue of $0.8 million. Total operating expenses for the period were $9.7 million, comprising $6.6 million in research and development expenses and $3.1 million in general and administrative expenses. The net loss for the quarter amounted to $8.6 million, translating to a net loss of $2.89 per share. As of June 30, 2024, the company had $21.4 million in cash, cash equivalents, and short-term investments, with no outstanding debt. This financial position is projected to sustain the operations of Oncternal into the first quarter of 2025.

Oncternal Therapeutics remains focused on addressing unmet medical needs in cancer treatment. ONCT-534, an investigational dual-action androgen receptor inhibitor (DAARI), has shown preclinical efficacy against both unmutated androgen receptors and various forms of androgen receptor aberrations in prostate cancer models. It is positioned as a potential therapeutic option for patients with metastatic castration-resistant prostate cancer (mCRPC) who are resistant to existing androgen receptor pathway inhibitors.

Additionally, ONCT-808 is an investigational autologous chimeric antigen receptor T (CAR T) cell therapy that targets the Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1). This therapy uses the binding domain from zilovertamab and has demonstrated preclinical activity against multiple hematological malignancies and solid tumors. Oncternal's optimized manufacturing process for ONCT-808 aims to reduce the time required for producing the individualized CAR T therapy, compared to currently approved CAR T products.

Zilovertamab, another investigational monoclonal antibody from Oncternal, inhibits the function of ROR1 and is being evaluated in combination with ibrutinib for mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and marginal zone lymphoma (MZL). Notably, a Phase 1/2 study showed a 100% progression-free survival (PFS) at 42 months in CLL patients with a p53 mutation/del(17p), a subgroup with limited treatment options. Zilovertamab is also being tested in combination with docetaxel for metastatic castration-resistant prostate cancer.

Oncternal Therapeutics is determined to bring forth breakthrough treatments for cancers with significant unmet needs, continually advancing its clinical programs and leveraging innovative approaches to improve patient outcomes.